MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TRUDI¿ NAVIGATION SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number FG200000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: an investigation was initiated by the manufacturer to investigate the issue.A software defect was discovered which affects the location accuracy of the curette tool on the trudi system display.The issue is being addressed as part of an internal corrective action.The history of customer complaints reported during the last year associated with trudi system #100121 was reviewed.3 similar complaints were found.The manufacturing record evaluation was performed on trudi system #100121, and no internal actions related to the reported complaint condition were identified.H9.Fda correction/ removal reporting no: 3005172759-09182023-001-c if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a functional endoscopic sinus surgery (fess) with a trudi¿ navigation system and a location inaccuracy occurred.It was reported that the trudi curette was inaccurate compared to the trudi nav suction device.The trudi curette was plugged into the white dongle, and trudi nav suction device was plugged into the purple.The caller reported that they isolated the problem to the trudi curette plugged into the white dongle, versus the trudi nav suction device connected to the purple dongle.The procedure continued using other navigated instruments that were accurate on the trudi navigation system.Additional information received indicated that when the accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.There were no error messages on the trudi¿ navigation system.The device was plugged in after the registration.There was no movement in the patient tracker and this would not explain the inaccuracy since the suction device remained accurate throughout the procedure.Per the standard environment for a fess - the patient had was tilted and moved when switching between surgeons and when switching from septoplasty to sinus work.This is almost always the case in this procedure type.No other device¿s shaft in proximity to an emitter pad¿s transmitter.There were no ferromagnetic materials placed withing the trudi zone and the crosshairs did not turn yellow.The difference in accuracy was greater than 2 mm.Ct images used as the primary image.About 200 slice ct scans.No other ct scans were used.This event was originally considered non-reportable, however, a product investigation identified a reportable product malfunction on 1-sep-2023.

Manufacturer Narrative

The manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 1-nov-2023, the product investigation was reopen to correct the following information: field h6.Investigation conclusions code corrected from "cause traced to component failure (d02)" to "cause traced to software coding (d18)".Additionally it was noticed the h6.Type of investigation code "analysis of data provided by user/third party (b15)" was inadvertently omitted from the 3500a initial medwatch, it has now been added.

• Brand Name: TRUDI¿ NAVIGATION SYSTEM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17839802
• MDR Text Key: 324785775
• Report Number: 2029046-2023-02197
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3005172759-09182023-001-
• Patient Sequence Number: 1
• Treatment: TRUDI CURETTE.; TRUDI NAV INSTRUMENT ADAPTER TAS (FRU).; TRUDI NAV SUCTION DEVICE.